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. 2018 Apr 25;2018(4):CD011526. doi: 10.1002/14651858.CD011526.pub2
Methods Randomized controlled trial
Length of follow‐up: 6 days
Participants Number: 206 enrolled children
Inclusion criteria: inpatients; well‐nourished infants and children aged 6 to 24 months with watery diarrhoea < 3 days duration, with 3 watery stools per day and at least 1 in the past 24 hours; mild‐to‐severe dehydration
Exclusion criteria: bloody diarrhoea, medications, malnutrition, systemic infection
Breastfeeding: included
Interventions Intervention group: diosmectite, dose 1 g in infants < 12 months and 1.5 g in older children, every 8 hours, plus zinc (dose not specified) for 5 days
Control group: placebo plus zinc
Outcomes Duration of diarrhoea (until first stool of pre‐diarrhoeal consistency)
Notes Location: Pakistan
Setting: urban
Cause of diarrhoea: not specified
Source of funding: not specified
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomized by lottery
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement. Mentions only "lottery method".
Blinding of participants and personnel (performance bias) All outcomes Low risk Use of placebo
Blinding of outcome assessment (detection bias) All outcomes Low risk Use of placebo
Incomplete outcome data (attrition bias) All outcomes Low risk Per‐protocol analysis. 10 losses to follow‐up (5%), 4 in intervention group, 6 in control group
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement. No protocol registered.
Other bias Low risk No other biases detected.